Label: ALCOHOL DISINFECTANT WIPES cloth

  • NDC Code(s): 41546-002-01
  • Packager: Zhejiang Huanghua Biological Technology Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 21, 2020

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  • DOSAGE & ADMINISTRATION

    Please do not place in drect sunlight or in a place with high temperature

  • INACTIVE INGREDIENT

    pure water

  • INDICATIONS & USAGE

    Open pouch by peeling the seal. Use wipes as directed.Reseal pouch after each use to preserve moisture.

  • ACTIVE INGREDIENT

    alcohol

    Benzalkamine

    2-methyl-4-isothiazoline-3-one

    propylene glycol

    2-phenoxyethanol

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • WARNINGS

    1,Please do not place in drect sunlight or in a place with high temperature
    2 If it gets into your eyes, wash itwith dle an water immedately
    3. Keep out of reach of children to avold salowing and choking
    4. This product is insoluble in water, please do not throw into the toilet
    5.This productis for extemal use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ALCOHOL DISINFECTANT WIPES 
    alcohol disinfectant wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41546-002
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE2.475 g  in 80 
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) (METHYLISOTHIAZOLINONE - UNII:229D0E1QFA) METHYLISOTHIAZOLINONE5.85 mg  in 80 
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL1.98 g  in 80 
    PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.44491 g  in 80 
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL202.5 mL  in 80 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code ZLT
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41546-002-0180 in 1 BAG; Type 0: Not a Combination Product05/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/21/2020
    Labeler - Zhejiang Huanghua Biological Technology Co., Ltd (415467459)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Huanghua Biological Technology Co., Ltd415467459manufacture(41546-002)
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